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Due to complexity and other attributes of biopharmaceuticals, it was and is expected that “classical preclinical safety evaluation procedures applied to SMTs would not predict the adverse effects of biopharmaceuticals.” [ed. note: SMT is an abbreviation for Small Molecule Therapeutics]. “Therefore,” the authors go on to say, “until sufficient experience was gained, the preclinical safety evaluation of biopharmaceuticals was carried out on a case-by-case basis.”

This Epub reviews the past 30 years, since the first biopharmaceuticals were developed, of preclinical safety experience, and tracks its evolution. Their thoughts, opinions, and conclusions include:

Our knowledge has now reached the point that a “preclinical safety evaluation procedure suited to biopharmaceuticals” is now a reasonable hope

According to the authors, this experience “shows that, as result of the risk-averse behavior of regulators and industry, classical procedures were taken as starting point although state-of-the-art knowledge on biopharmaceuticals was directed towards creating a new procedure, driven by the specific properties of biopharmaceuticals.”

The authors criticize current Regulatory Guidance for the preclinical safety evaluation of biopharmaceuticals because, in their opinion, “it employs a checkbox approach.”

They conclude by reminding us that “The adverse effects induced by biopharmaceuticals are on-target or immune system-induced,” and therfore: “the preclinical safety evaluation should not be standardized, but rather driven by product specific safety concerns.”

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